About the study

The purpose of this study is to identify patients who may be eligible to participate in a separate Phase 2/3 treatment study evaluating an individualized neoantigen vaccine GRANITE for first line (1L) maintenance treatment of metastatic, microsatellite-sable colorectal cancer (MSS-CRC) sponsored by Gritstone bio. This may include the manufacturing of an individualized vaccine, which involves neoantigen prediction and generating a vaccine targeting neoantigens.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. signed and dated ICF prior to initiation of study-specific procedures
2. histologically confirmed metastatic CRC who are planned for or who have received no more than one cycle of first-line treatment in the advanced/metastatic setting with a fluoropyrimidine and oxaliplatin in combination with bevacizumab
3. measurable and unresectable disease according to RECIST v1.1
4. known KRAS status
5. availability of FFPE tumor specimens from biopsy within the previous 12 months for sequencing and neoantigen prediction
6. ≥ 12 years of age
7. ECOG performance status of 0 or 1 or equivalent for patients of 12-17 years of age
8. adequate organ function (further defined in protocol)

Exclusion criteria

1. known microsatellite instability (MSI)hi disease based on institutional standard
2. known tumor mutation burden <1 nonsynonymous mutations/MB
3. patients with BRAF V600E mutations LOCALIZED COLON CANCER

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.